Callisto Pharmaceuticals Announces Major Strategic Initiative for Guanilib in GI Disorders



    Callisto Pharmaceuticals, Inc. (AMEX: KAL; FWB: CA4), a developer
    of new drug treatments in the fight against cancer and
    gastrointestinal disorders and diseases, announced today a major
    strategic initiative to develop Guanilib, its guanylate cyclase C
    receptor (GCCR) agonist. Guanilib will be developed primarily for
    chronic constipation and constipation-predominant irritable bowel
    syndrome (IBS-C).

    "This is a major new development for Callisto," said Dr. Gary S.
    Jacob, Chief Executive Officer of Callisto. "The value for products in
    this class was recently set in a partnership deal between Microbia
    Inc. and Forest Laboratories (NYSE: FRX). That deal provided upfront
    and milestone payments to Microbia of up to $330 million - and that
    was for essentially a 50/50 profit split for the US only. We have the
    only other compound in this class. We were the first company to
    develop GCCR agonists based on the natural human intestinal hormone
    uroguanylin, and our patent on Guanilib issued in May, 2007, giving us
    a proprietary position with our drug. We are now behind Microbia but
    we hope to have a compound that is best in class."

    As part of its initiative, Callisto announced plans to file an IND
    for Guanilib in the first quarter of 2008, and initiate a Phase 1
    trial shortly thereafter. Callisto is also shifting the immediate
    development focus from gastro-inflammatory diseases to chronic
    constipation and IBS-C. "Callisto will devote at least half of its
    available funds exclusively for Guanilib development," said Dr. Jacob.
    "In addition to our cancer products, we now aim to become a leading GI
    drug development company. Drugs in these markets have very large sales
    potential, and we will build the organization and devote the resources
    needed to realize this ambition."

    About Guanilib

    Guanilib (also called SP-304) is a potent analog (synthetic
    molecule) of uroguanylin developed by Callisto scientists, and is
    proprietary to Callisto. Guanilib has been demonstrated to be superior
    to the natural hormone, uroguanylin, in its biological activity,
    protease stability and pH characteristics. The compound is currently
    undergoing pre-clinical animal safety studies as a treatment for
    chronic constipation and IBC-C. The compound is not absorbed
    systemically and demonstrates a very good safety profile. Callisto
    plans to initiate clinical trials of Guanilib in early 2008.

    About Chronic Constipation and Irritable Bowel Syndrome

    Chronic constipation is a very common condition. Up to 26 million
    Americans suffer from the condition and of these about 5 million have
    a severe problem. The prevalence is similar in other developed
    countries. Patients with chronic constipation often experience hard
    stools, straining during bowel movements and not enough bowel
    movements during the week. People with chronic constipation can
    experience serious discomfort which adversely affects their ability to
    work and their quality of life.

    Up to one sixth of adults experience Inflammatory Bowel Syndrome
    (IBS), a condition marked by disturbed bowel function and abdominal
    pain. IBS patients can have three different sets of symptoms;
    diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and
    mixed or alternating disorder (IBS-M). About 35% of patients suffer
    from IBS-C. IBS accounts for 12% of adult visits to primary care
    physicians in the US.

    There are currently few therapies available for chronic
    constipation or IBS-C. The main product in this market, Zelnorm from
    Novartis Pharmaceuticals (NYSE: NVS), was withdrawn due to
    cardiotoxicity in April 2007 in the US. In 2006 Zelnorm sold about
    $561 million with about a 30% growth rate at the time of withdrawal.

    About Callisto Pharmaceuticals, Inc.

    Callisto is a biopharmaceutical company focused on the development
    of new drugs to treat various forms of cancer and gastrointestinal
    diseases. Callisto's drug candidates include two anti-cancer agents as
    well as a drug for gastrointestinal disorders. One of the Company's
    lead drug candidates, Atiprimod is presently in a Phase II clinical
    trial in advanced carcinoid cancer patients, a neuroendocrine tumor,
    and in a Phase I/IIa human clinical trial in relapsed or refractory
    multiple myeloma patients. Another anti-cancer drug, L-Annamycin, is
    being developed as a treatment for forms of relapsed or refractory
    acute leukemia, a currently incurable blood cancer. L-Annamycin is
    currently in a Phase I clinical trial in adult relapsed or refractory
    acute lymphocytic leukemia, and in a Phase I clinical trial in
    children and young adults with refractory or relapsed acute
    lymphocytic leukemia or acute myelogenous leukemia. L-Annamycin, a
    member of the anthracycline family of proven anti-cancer drugs, has a
    novel therapeutic profile, including potential activity against
    multi-drug resistant tumors and significantly reduced cardiotoxicity,
    or damage to the heart, compared to currently available drug
    alternatives. Callisto also has a proprietary drug Guanilib in
    preclinical development for gastro-intestinal disorders. Callisto is
    also listed on the Frankfurt Stock Exchange under the ticker symbol
    CA4. More information is available at http://www.callistopharma.com.

    Forward-Looking Statements

    Certain statements made in this press release are forward-looking.
    Such statements are indicated by words such as "expect," "should,"
    "anticipate" and similar words indicating uncertainty in facts and
    figures. Although Callisto believes that the expectations reflected in
    such forward-looking statements are reasonable, it can give no
    assurance that such expectations reflected in such forward-looking
    statements will prove to be correct. As discussed in the Callisto
    Pharmaceuticals Annual Report on Form 10-K for the year ended December
    31, 2006, and other periodic reports, as filed with the Securities and
    Exchange Commission, actual results could differ materially from those
    projected in the forward-looking statements as a result of the
    following factors, among others: uncertainties associated with product
    development, the risk that products that appeared promising in early
    clinical trials do not demonstrate efficacy in larger-scale clinical
    trials, the risk that Callisto will not obtain approval to market its
    products, the risks associated with dependence upon key personnel and
    the need for additional financing.